(116 days)
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
Here's a breakdown of the requested information, based on the provided FDA 510(k) summary for the HF-Etchant Hydrofluoric Acid Etching Gel.
Important Note: The provided document is a 510(k) summary for a medical device (HF-Etchant Hydrofluoric Acid Etching Gel), not an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML studies (like expert adjudication, MRMC studies, training/test set sample sizes, and ground truth establishment for AI) are not applicable to this type of submission and will be marked as such. The device described is a chemical etching gel, not a software algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Standard SOP) | Reported Device Performance |
|---|---|
| Thermostability | Qualified |
| Hydrofluoric acid content | Qualified |
| Rotational viscosity value | Qualified |
| pH value | Qualified |
| Shelf Life (2-year real-time stability) | Reliable and Effective |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for formal "test sets" as would be done for an AI/ML algorithm. The performance was determined through internal testing of the device itself.
- Data Provenance: Not explicitly stated, but the testing was "according to Internal standard SOP of the company." This implies in-house testing by Rizhao HuGe Biomaterials Company, Ltd. (China).
- Retrospective or Prospective: Not applicable in the context of an AI/ML algorithm. The performance testing appears to be prospective (i.e., conducted on the manufactured device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a chemical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for its properties (like pH, viscosity) is determined by standard chemical and physical measurement techniques.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML device. An MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm.
7. The Type of Ground Truth Used
- For physical and chemical properties (Thermostability, Hydrofluoric acid content, Rotational viscosity value, pH value): The ground truth is established by quantitative measurements against the company's internal standard operating procedures (SOPs).
- For shelf life: The ground truth is established through real-time stability testing over a 2-year period.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.